Thyroid NeoplasmsPhase 2NCT00094055

Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer

A Phase 2 study testing AG013736 in people with Thyroid Neoplasms, run by Pfizer at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Thyroid Neoplasms
What is being tested?: AG013736
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 9 sitesUnited States
Study dates: Sep 2004to Jan 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically documented thyroid cancer with metastases.
Failure of radioactive iodine (131I) to control the disease or radioactive iodine (131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor)

Who cannot join

Central lung lesions involving major blood vessels (arteries or veins).(Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
Patients with a history of hemoptysis

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Aurora, Colorado, 80010
Pfizer Investigational Site
Baltimore, Maryland, 21231-1000
Pfizer Investigational Site
Baltimore, Maryland, 51231
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Houston, Texas, 77030-4009
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
Santa Monica, California, 90404

Other trials in United States

About this study

Official title: Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131 I Treatment

This is a Phase 2 study being conducted at multiple centers in the United States. Patients having thyroid cancer that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that was not controlled by previous treatment with radioactive iodine (131I) or not be good candidates for such treatment. The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic thyroid cancer as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

Conditions: Thyroid Neoplasms
Being tested: AG013736
Medical subject headings: Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AG013736Drug
AG013736, tablets 5 mg BID daily until tumor progression or toxicity

Study groups in NCT00094055
Study group	Role	What they receive
Axitinib [AG-013736]	Experimental	Not described Receives: Drug: AG013736

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Objective Response (OR)
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks

Secondary outcomes (3)

Progression-Free Survival (PFS)
Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Measured: Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks
Duration of Response (DR)
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Measured: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks
Overall Survival (OS)
Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.
Measured: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2004Jan 2009

First posted11 Oct 2004 (estimated)
Study startSep 2004
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00094055
Sponsor's protocol ID: A4061014
Status last verified: Jun 2012
First submitted: 8 Oct 2004
Last updated: 26 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cohen EE, Tortorici M, Kim S, Ingrosso A, Pithavala YK, Bycott P. A Phase II trial of axitinib in patients with various histologic subtypes of advanced thyroid cancer: long-term outcomes and pharmacokinetic/pharmacodynamic analyses. Cancer Chemother Pharmacol. 2014 Dec;74(6):1261-70. doi: 10.1007/s00280-014-2604-8. Epub 2014 Oct 15.
PubMed 25315258

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Thyroid Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer Who Are Refractory to or Not Suitable Candidates for 131 I Treatment
ClinicalTrials.gov ID: NCT00094055
Acronym / sponsor ID: A4061014
Conditions: Thyroid Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2004
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 11 Oct 2004 (estimated)
Results: Posted 30 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Axitinib [AG-013736]	Experimental	Drug: AG013736

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Histologically documented thyroid cancer with metastases.
Failure of radioactive iodine (131I) to control the disease or radioactive iodine (131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor)

Key exclusion criteria (2 listed)

Central lung lesions involving major blood vessels (arteries or veins).(Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.)
Patients with a history of hemoptysis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AG013736AG013736, tablets 5 mg BID daily until tumor progression or toxicity	Drug	Axitinib [AG-013736]

Primary outcome

Percentage of Participants With Objective Response (OR)
Time frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

3 secondary outcomes

Progression-Free Survival (PFS)
Time frame: Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks
Duration of Response (DR)
Time frame: Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks
Overall Survival (OS)
Time frame: Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant

Results and safety

Results posted to the registry on 30 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Axitinib	60	0

Primary outcome: Percentage of Participants With Objective Response (OR)

Time frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Axitinib n = 60
Value	38.3 (26.1 to 51.8)

Population analysed: Intent to treat (ITT) population included all participants who received at least 1 dose of study medication.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Axitinib	32 of 60 (53.3%)	60 of 60 (100%)	Not reported

Limitations and caveats (from the sponsor): Population pharmacokinetics and plasma concentrations of soluble proteins were not presented, as the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25315258Cohen EE, Tortorici M, Kim S, Ingrosso A, Pithavala YK, Bycott P. A Phase II trial of axitinib in patients with various histologic subtypes of advanced thyroid cancer: long-term outcomes and pharmacokinetic/pharmacodynamic analyses. Cancer Chemother Pharmacol. 2014 Dec;74(6):1261-70. doi: 10.1007/s00280-014-2604-8. Epub 2014 Oct 15.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Thyroid Neoplasms

Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
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Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AG013736 in people with Thyroid Neoplasms, run by Pfizer at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Objective Response (OR) (time frame: Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094055, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.